Imaging Predictors of Treatment Response in Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00367341
First received: August 18, 2006
Last updated: November 21, 2013
Last verified: November 2013
Results First Received: November 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: escitalopram
Behavioral: Cognitive Behavioral Therapy (CBT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Escitalopram escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.

Participant Flow:   Overall Study
    Escitalopram     Cognitive Behavioral Therapy  
STARTED     42     40  
COMPLETED     40     40  
NOT COMPLETED     2     0  
Physician Decision                 1                 0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Escitalopram escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Escitalopram     Cognitive Behavioral Therapy     Total  
Number of Participants  
[units: participants]
  42     40     82  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     42     40     82  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.2  ± 6.8     42.2  ± 9.5     41.68  ± 8.22  
Gender  
[units: participants]
     
Female     26     22     48  
Male     16     18     34  
Region of Enrollment  
[units: participants]
     
United States     42     40     82  



  Outcome Measures
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1.  Primary:   Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks   [ Time Frame: Measured at week 12 ]

2.  Secondary:   Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks   [ Time Frame: Measured at week 12. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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